Job Title:
Clinical Systems and Analytical Reporting (CSAR) Study Design and Programming Sr. Manager
Department:
Clinical
Company:
Amgen
Location:
Hyderabad, India
Work Location Type:
On Site
Date Posted:
March 7, 2025
Application Deadline:
Not specified
Job ID:
R-209593
Job Summary:
Amgen is seeking a Senior Manager to lead Study Design and Programming operations within the Clinical Systems and Analytical Reporting (CSAR) function. This individual will oversee internal and external partners to deliver system support and clinical database solutions. The role involves strategic leadership, project oversight, people management, and cross-functional collaboration, reporting to the Sr. Director/Director of CSAR.
Key Responsibilities:
Lead and manage the Study Design and Programming function in CSAR.
Provide line management, mentorship, and coaching to develop team members.
Manage internal and vendor-based resources and ensure quality deliverables.
Oversee clinical system project planning, progress, and reporting.
Develop and implement strategic goals for CSAR and GDO.
Drive system/process improvement initiatives.
Ensure compliance and documentation in accordance with SOPs and regulations.
Act as a subject matter expert (SME) and internal coach on CSAR operations.
Partner with functional service providers and external vendors.
Ensure consistent and efficient use of EDC systems like Rave and Veeva.
Support and respond to audits and regulatory inspections.
Knowledge & Skills:
Good Clinical Practice (GCP)
Performance management and analytical thinking
Drug development and clinical trial processes
Clinical database systems and reporting platforms (e.g., Rave EDC, Veeva EDC)
Systems development lifecycle (SDLC)
Vendor oversight, including FSP/MSP models
Project and program management
Experience leading global, cross-functional teams
Regulatory knowledge and quality risk management
Talent management and training program development
Basic Qualifications:
One of the following:
Doctorate + 2 years of relevant experience
Master’s degree + 8–10 years of relevant experience
Bachelor’s degree + 10–14 years of relevant experience
Diploma + 14–18 years of relevant experience
Relevant Fields: Computer Science, Business Administration, Life Sciences, or a medically related discipline
Industry Experience: Biopharmaceutical clinical research experience (e.g., biotech, pharma, CRO)
People Management: Previous line management experience is required
Preferred Qualifications:
Extensive data management experience in pharma/biotech
Experience working in global organizations
Familiarity with CRO/vendor oversight (e.g., labs, imaging, IRT)
Proven leadership in system transformation projects
Involvement in strategic planning and outsourcing strategies
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer, committed to providing equal employment opportunity regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected characteristic. Reasonable accommodations are provided upon request.
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